- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06870149
Cognitive Groove (Brought to You by GERAS DANCE) (GERAS DANCE)
Does Cognitive Groove (Brought to You by GERAS DANCE) Improve Physical Performance in Community-Dwelling Older Adults With Frailty: A Parallel Randomized Controlled Trial
The goal of this clinical trial is to determine the effect of a community-based rehabilitation intervention (Cognitive Groove, Brought to you by GERAS DANCE), compared to usual care, on clinical outcomes in community-dwelling older adults living with frailty. The main questions it aims to answer are:
- In community-dwelling older adults living with frailty, is Cognitive Groove more effective than usual care in improving functional movement, physical performance and strength?
- In community-dwelling older adults living with frailty is Cognitive Groove more effective than usual care in improving frailty status, fear of falling, balance confidence, mood, cognition, grip strength, activities of daily living, life space mobility, loneliness, and quality of life?
- As a community-based rehabilitation intervention, is Cognitive Groove a cost-effective intervention embedded within the community for older adults living with frailty after 12-months?
Participants will participate in Cognitive Groove classes twice per week for 3 months or receive no intervention (usual care).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patricia Hewston, PhD
- Phone Number: 74161 905-521-2100
- Email: hewstonp@hhsc.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8M 1W9
- Recruiting
- Geras Centre for Aging Research, St. Peter's Hospital, Hamilton Health Sciences
-
Contact:
- Patricia Hewston, PhD
- Phone Number: 74161 905-521-2100
- Email: hewstonp@hhsc.ca
-
Principal Investigator:
- Alexandra Papaioannou, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Community-dwelling aged ≥65 years
- At high risk for mobility disability/functional limitations as assessed by the FRAIL Scale ≥2
- Able to ambulate independently (25 m) with or without an assistive device
- Able to follow two-step instructions
- Medical clearance from referring clinician, or for self-referrals, medical clearance from family physician to safely participate in exercise
- Can arrange transportation to the YMCA up to 2 times per week
Exclusion Criteria:
- Unable to speak or understand English
- Current regular participation in a structured exercise program or receiving active physical therapy services
- Severe cardiac or pulmonary disease
- Unstable angina or heart failure
- Severe osteoarthritis (e.g., awaiting joint replacement)
- Parkinson's disease or other progressive neurological disorder
- Receiving palliative care
- Travel/commitments requiring missing more than two weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Groove (GERAS DANCE)
Classes will occur twice per week for 3 months.
Classes follow a consistent sequence of activities (orientation and socialization [10-mins]; warm-up [5-mins]; structured dance [30-mins]; cool-down [5-mins]; socialization and review of weekly hand-outs for balance exercises [10-mins].
The curriculum schedule includes five foundations and seven routines.
Cognitive Groove (GERAS DANCE) foundations emphasize learning the ABCs of movement and increasing participants' confidence to move their bodies forward and backward and side-to-side with improved speed and rhythmicity.
Cognitive Groove (GERAS DANCE) routines combine the foundational skills into full choreographed dances to music from the '50s and '60s (e.g., rock and roll, jazz, salsa, cha cha cha, rhythm soul, swing, disco, and Bollywood).
Participants will receive an intervention-specific study manual that describes the homework exercises for each week.
|
Cognitive Groove (GERAS DANCE) presents a novel approach to increasing or maintaining independence and quality of life by improving physical performance and mobility using reminiscent music and rhythmic movement in a fun, safe environment.
Cognitive Groove was designed to meet the complex needs of older adults with frailty.
Our pilot quasi-experimental studies have demonstrated Cognitive Groove results in clinically significant improvements in walking speed by 0.1 m/s with enhanced temporal-spatial walking parameters and improved lower extremity function, including balance and chair stands.
Other Names:
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No Intervention: Usual Care
The control arm participants will continue with their usual care and normal activities.
They will not receive any intervention during the study but will be given the opportunity to participate in Cognitive Groove (GERAS DANCE) programming after the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Physical Performance
Time Frame: Baseline and 3-months
|
Physical function will be assessed with the Short Performance Physical Battery [total score].
Higher scores indicate better physical performance [range 0-12].
|
Baseline and 3-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Walking Speed
Time Frame: Baseline and 3-months
|
Walking speed will be assessed with the 400-m Walk Test [walking speed, m/s].
Faster walking speeds indicate better performance.
|
Baseline and 3-months
|
|
Change in Functional Mobility
Time Frame: Baseline and 3-months
|
Functional mobility will be assessed with the Timed Up and Go (TUG) Test [total time, s].
A higher score indicates a greater falls risk (greater or equal to 12 sec) and lower functional mobility.
|
Baseline and 3-months
|
|
Change in Dual Task Ability
Time Frame: Baseline and 3-months
|
Dual-task ability will be assessed by the TUG-Cognitive (Dual Task Ability) [total time, s].
Higher time indicates worse performance.
|
Baseline and 3-months
|
|
Change in Static Postural Control
Time Frame: Baseline and 3-months
|
Static postural control will be assessed by the Single Leg Stance Test [total time, s].
Higher scores indicate better postural control.
|
Baseline and 3-months
|
|
Change in Hand Grip Strength
Time Frame: Baseline and 3-months
|
Hand grip strength will be assessed with a handgrip dynamometer [kg].
Higher measures indicate higher grip strength.
|
Baseline and 3-months
|
|
Change in Cognition
Time Frame: Baseline and 3-months
|
Cognition will be assessed with the Montreal Cognitive Assessment [total score].
Higher scores indicate better cognition [range 0-30].
|
Baseline and 3-months
|
|
Change in Cognition
Time Frame: Baseline and 3-months
|
Change in cognition will be assessed using the Trail Making Test (TMT) [total time, s].
Higher time indicates worse performance.
|
Baseline and 3-months
|
|
Change in Cognition
Time Frame: Baseline and 3-months
|
Cognition will be assessed using the Digit Symbol Substitution Test (DSST) [total score].
Higher scores indicate better cognition [range 0-100].
|
Baseline and 3-months
|
|
Change in Frailty
Time Frame: Baseline and 3-months
|
Frailty will be assessed with the Fit-Frailty Index [total score].
Higher scores indicate greater frailty [range 0-1].
|
Baseline and 3-months
|
|
Change in Fear of Falling
Time Frame: Baseline and 3-months
|
Fear of falling will be assessed by the Falls Efficacy Scale International (FES-I) [total score].
Higher scores indicate greater fear of falling [range 16-64].
|
Baseline and 3-months
|
|
Change in Balance Confidence
Time Frame: Baseline and 3-months
|
Balance confidence will be assessed by the Activities-specific Balance Confidence (ABC) Scale [total score].
Higher scores indicate higher confidence [range 0-100].
|
Baseline and 3-months
|
|
Change in Depression/Mood
Time Frame: Baseline and 3-months
|
Depression and mood will be assessed with the Patient Health Questionnaire-9 (PHQ-9) [total score].
Higher scores indicate more depressive symptoms [range 0-27].
|
Baseline and 3-months
|
|
Change in Loneliness
Time Frame: Baseline and 3-months
|
Loneliness will be assessed by the University of California Los Angeles (UCLA) Loneliness Scale [total score].
Higher scores in indicate higher loneliness [range 20-80].
|
Baseline and 3-months
|
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Change in Basic Activities of Daily Living
Time Frame: Baseline and 3-months
|
Activities of daily living will be assessed with the Katz activities of daily living questionnaire [total score].
Lower scores indicate greater impairment [range 0-6].
|
Baseline and 3-months
|
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Change in Instrumental Activities of Daily Living
Time Frame: Baseline and 3-months
|
Activities of daily living will be assessed with Lawton instrumental activities of daily living questionnaire [total scores].
Lower scores indicate greater impairment [range 0-8].
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Baseline and 3-months
|
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Change in Life Space Mobility
Time Frame: Baseline and 3-months
|
Life space mobility will be assessed with the Life Space Assessment [total score].
Higher scores indicate a larger life space [range 0-120].
|
Baseline and 3-months
|
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Change in Health-related Quality of Life
Time Frame: Baseline, 3-months, and 12-months
|
Health-related quality of life will be assessed using the Health Utilities Index (HUI).
Higher scores indicate better health-related quality of life [range 0-1].
|
Baseline, 3-months, and 12-months
|
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Change in Healthcare Utilization
Time Frame: Baseline, 3-months, and 12-months
|
Number of emergency room visits and hospitalizations will be recorded.
Higher number of visits indicates higher healthcare utilization.
|
Baseline, 3-months, and 12-months
|
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Change in Healthcare Utilization
Time Frame: Baseline, 3-months, and 12-months
|
Healthcare services use will be recorded.
Higher number of visits, medications, etc., indicates higher healthcare utilization.
|
Baseline, 3-months, and 12-months
|
|
Change in Falls
Time Frame: Baseline to 3-months
|
Number of falls will be assessed by self-report and electronic health record.
|
Baseline to 3-months
|
|
Change in Falls-Related Injuries
Time Frame: Baseline to 3-months
|
Number of falls-related injuries will be assessed by self-report and electronic health record.
|
Baseline to 3-months
|
|
Change in Mobility
Time Frame: Baseline to 3-months
|
Change in mobility will be assessed by the total number of steps taken daily (e.g., Actigraph accelerometer).
Higher number of steps indicates greater mobility.
|
Baseline to 3-months
|
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Adherence
Time Frame: Baseline to 3-months
|
Class attendance and homework completion will be recorded [total number completed].
Higher class attendance and homework completion indicates greater adherence.
|
Baseline to 3-months
|
|
Change in Walking Speed
Time Frame: Baseline to 3-months
|
Change in walking speed will be assessed by 8-ft walking speed [m/s].
Faster walking speeds indicate better performance.
|
Baseline to 3-months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Individual-level Economic Evaluation
Time Frame: Baseline, 3-months, and 12-months
|
Individual-level economic evaluations will be assessed by changes in direct medical costs and effectiveness outcomes (e.g., quality-adjusted life years - QALYs), calculate and compare the incremental cost-effectiveness ratio (ICER) (e.g., $/ QALY gained, $/ a visit averted) against a willingness-to-pay threshold ($50,000/QALY) to show if this program represents good value for money.
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Baseline, 3-months, and 12-months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandra Papaioannou, MD, McMaster University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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